Regulatory Strategy

  • Strategic guidance, planning and advice for regulatory submissions to health authorities
  • Support developing target product profiles and draft product labelling
  • Key message mapping to detail the strategy for supporting the target product profile throughout the submission dossier
  • Storyboarding to develop clear, concise and data-driven messaging for critical topics in the submission dossier

Medical Writing

  • Regulatory submissions: US New Drug Applications (NDAs), US Biologics Licensing Applications (BLAs), US Investigational New Drug (IND) applications, EU Marketing Authorisation Applications (MAAs)
  • Agency interactions: EU Scientific Advice, FDA Type B / Type C meetings and pre-IND meetings, FDA Advisory Committee Briefing Documents
  • Paediatrics: EU Paediatric Investigation Plans (PIPs) and US Pediatric Study Plans (PSPs)
  • Regulatory responses: EU centralised procedure Day 120 and Day 180 responses and FDA written responses
  • Clinical Study Protocols and Protocol amendments (Phase 1 to 4)
  • Investigator Brochures
  • Safety and pharmacovigilance documents: Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), patient safety narratives

Quality Control

  • 100% data checks vs verified sources
  • Checks for internal document consistency
  • Checks for consistency and alignment with relevant external documents
  • Spelling, grammar, house style, formatting and other editorial checks